FDA Looking For Consulting Org To Run DSCSA Pilots - RxTrace.com

Dirk Rodgers of RxTrace.com writes about an RFP the FDA issued last month that is due August 13th... Check it out, in full, on RxTrace.com...
Last week the FDA quietly posted a Request For Proposal (RFP) on the FedBizOpps.gov government bidding site for a consulting organization to design and implement a program of pilot projects that explore and evaluate methods to enhance the safety and security of the pharma supply chain.  The scope of work is:

“Development and implementation of a program for the pilot projects will include, but is not limited to: development of the program structure, determination of the scope of the pilot projects and what issues should be covered, ensuring the pilot project design fulfills the requirement of the DSCSA, development of an enrollment process for potential participants, development of timing and schedule, development of monitoring and reporting schedule, development of pilot project metrics and evaluation plan; and development of a communication plan. The pilot project(s) developed under the DSCSA need to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain, through

1. utilization of the product identifier for tracing of a product throughout the supply chain and may include verification of product identifier, including the use of aggregation and inference;

2. improvement of the technical capabilities of each sector and subsector to comply with systems and processes needed to utilize the product identifiers to enhance tracing of a product; and

3. identification of system attributes that are necessary to implement the requirements established under the DSCSA.”

The RFP was posted on July 31, 2015 and responses must be submitted by midnight on August 13, 2015.  As part of developing the program, the contractor will also help the FDA run a public workshop and docket to collect ideas and comments that will help guide the design of the pilots.  The “period of performance” is eight months from date of the award.
Check out the full article at RxTrace.com...

What GTIN would you use under this co-marketing scenario?

I saw this conversation on Linked In and felt that it was worthy to repost here for preserving...
Here’s the scenario:

A large multi-national manufactures and packages pharmaceutical finished goods. One presentation of these finished goods are sold in the US through a Partner (co-marketing arrangement). The Artwork and GTIN (NDC) of the product is that of the Partner. However the manufacturing authorization holder (MAH) is the large multi-national brand owner. With Serialization according to the DSCSA, should the GTIN remain that of the Partner? Or, would it need to revert to the MAH?
My belief is that it would not change – remain that of the Partner. Curious if you have come across this and if so, what approach you would take. 

FDA Warns of Bogus Botox - Case for SAP ATTP?

Counterfeit Botox may have been distributed to doctors' offices and medical clinics across the United States, the U.S. Food and Drug Administration warns.

The bogus Botox -- which is considered unsafe and should not be used -- was sold by an unlicensed supplier not authorized to ship or distribute drug products in the United States, the FDA said in a news release.

Packaging similarities between the fakes and the FDA-approved Botox, which is made by Allergan (100 units/vial), could cause health care professionals to mistake one for the other.

Approved Botox displays the active ingredient as "OnabotulinumtoxinA" on the outer carton and vial, the FDA said.

The outer carton of the counterfeit version says the active ingredient is "Botulinum Toxin Type A" instead of "OnabotulinumtoxinA," according to the agency.

The FDA said the counterfeit product also can be identified in other ways. For instance, the vial is missing the lot number.

Read full article here : http://mobile.philly.com/health/?wss=/philly/health&id=300685841

The DSCSA Product Identifier On Drug Packages - Dirk Rodgers

According to the Drug Supply Chain Security Act (DSCSA), manufacturers must apply a new “Product Identifier” on all of their prescription drug products by November 27, 2017 (Repackagers by that date in 2018).  The DSCSA Product Identifier is defined this way:

“PRODUCT IDENTIFIER.—
The term ‘product identifier’ means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.”  (Section 581[14])

US FDA Amends eMDR Rules to align with Unique Device Identification Program - Posted on RAPS

US medical device regulators at the Food and Drug Administration (FDA) have issued correcting amendments to their post-market electronic Medical Device Reporting (eMDR) requirements to eliminate any disparities between those rules and their Unique Device Identification (UDI) system.

All changes will affect federal regulation 21 CFR Part 803 covering medical device reporting. Among the changes in the FDA final rule are requirements for what manufacturers, user facilities and importers should include in adverse event reports: identifying device number such as model, catalog, serial or lot number; expiration date; and UDI appearing on device label or package.


View full article on RAPS -> US FDA Amends eMDR Rules to align with Unique Device Identification Program

Pharma Serialization Update - April

Bill Fletcher highlights a few key deadlines looming for Pharma Serialization:

1. The FDA enforcement discretion not to enforce the transaction document aspects of the Drug Supply Chain Security Act (DSCSA) ends May 1. Companies who may have chosen to spend more time working out kinks in their transaction document (TD) may be running out of time.  
2. There is controversy with the way shipper cases are tracked in Brazil.
3. Companies selling into Brazil will now need to collect traceability data from 3 LOTs by December of this year. 
4. Chinese traceability is fully effective this December.  
5. New requirements in India for primary packages are creating very onerous designs on manufacturers
6. EU delegated acts for Falsified Medicines is expected in the next couple of months. Encoding will include GTIN, country reimbursement code, LOT expiration date and serial number in human readable and encoded in a GS1 DataMatrix symbol

Bill Fletcher - Pharma-Logic

FDA Issues Guidance for Track-and-Trace of Pharmaceuticals, TwoImportant Takeaways for 3PLs by Jan. 1

The U.S. Food and Drug Administration issued guidance for the Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, and Prescription Drugs. The document establishes initial standards for the interoperable exchange of product tracing information (transaction history (TH), transaction statement (TS), transaction information (TI) in paper or electronic format. #1: Track […]


http://iwla1891.com/2014/12/03/fda-issues-guidance-for-track-and-trace-of-pharmaceuticals-two-important-takeaways-for-3pls-by-jan-1/